Tags: gene therapy | duchenne muscular dystrophy | elevidys | fda | shipments | stop

Report: FDA to Stop Shipments of Gene Therapy

doctor removing part of DNA as concept of gene editing
(Dreamstime)

Friday, 18 July 2025 01:44 PM EDT

The U.S. Food and Drug Administration will request Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reuters on Friday.

Shares of the company extended losses and were down nearly 35% in afternoon trading, after being halted briefly.

The FDA's request follows the death of two teenage boys who received Elevidys, a gene therapy approved in the United States to treat a muscle-wasting condition called Duchenne muscular dystrophy.

Both the boys were non-ambulatory patients, or those who could not walk independently, and in June, Sarepta had stopped shipments of the therapy to that patient group.

Sarepta did not immediately respond to a Reuters request for comment.

Earlier on Friday, the company disclosed the death of another patient who received one of its experimental gene therapies, deepening investor concern over use of its treatments.

A 51-year-old man enrolled in an early-stage trial of its gene therapy, SRP-9004, for the treatment of limb-girdle muscular dystrophy (LGMD) died from acute liver failure last month.

FDA Commissioner Marty Makary told Bloomberg News in an interview that he was "taking a hard look" at whether a gene therapy from Sarepta should remain on the market.

© 2025 Thomson/Reuters. All rights reserved.


Health-News
The U.S. Food and Drug Administration will request Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reuters on Friday.Shares of the company extended losses and were down nearly 35% in afternoon...
gene therapy, duchenne muscular dystrophy, elevidys, fda, shipments, stop
200
2025-44-18
Friday, 18 July 2025 01:44 PM
Newsmax Media, Inc.

Sign up for Newsmax’s Daily Newsletter

Receive breaking news and original analysis - sent right to your inbox.

(Optional for Local News)
Privacy: We never share your email address.
Join the Newsmax Community
Read and Post Comments
Please review Community Guidelines before posting a comment.
 
Find Your Condition
Get Newsmax Text Alerts
TOP

The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Read Newsmax Terms and Conditions of Service.

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved
NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved